EMA Publishes Annual Report

Apr 30, 2014

By PharmTech Editors

The European Medicines Agency (EMA) released its annual report detailing drug approvals and agency projects completed in 2013, as well as initiatives started in the past year. According to the report, EMA recommended 81 drugs for marketing authorization in 2013, up from 57 in 2012. There was also an increase in the number of drugs containing new active substance; however, the number of generic drugs remained stable. EMA also recommended two new advance-therapy drugs in 2013 and approved 11 orphan drugs.

The report also highlights projects, initiatives, and achievements made by the agency in 2013 including access to clinical trial data as part of a marketing authorization application, advancement in patient access to medicine, reorganization of the agency, and implementation of new legislation. The report also details the agency’s pharmacovigilance activities as part of implementation of the European Union’s pharmacovigilance legislation.